Status: Finalised First registered on: 24/02/2014
Last updated on: 21/03/2019
1. Study identification
EU PAS Register NumberEUPAS5896
Official titleRisk of Febrile Convulsions after 1st dose MMRV vaccination in comparison to MMR and MMR+V vaccination.
Study title acronymMMRV 1st dose
Study typeObservational study
Brief description of the studyIn July 2006, Priorix-Tetra™, a combined measles-mumps-rubella-varicella (MMRV) vaccine, was licensed in Germany. Since a post-licensure study (Jacobsen et al., 2009) had shown a more than twofold elevated risk of febrile convulsions (FC) after first dose vaccination with the combined MMRV vaccine ProQuad® compared to separately administered MMR and V vaccines (MMR+V), a study investigating the risk of FC for Priorix-Tetra™ was requested by the Paul-Ehrlich Institute, the regulatory agency responsible for vaccine licensing and safety in Germany. A retrospective matched cohort study was performed to provide risk estimates of FC after a first dose of Priorix-Tetra™ (MMRV) compared to MMR and MMR+V in pre-defined risk intervals. All children born between 01.01.2004 and 31.12.2008 who received a first dose of MMRV vaccine were matched to children vaccinated with MMR, MMR+V and MMR or MMR+V, respectively, by sex, age, month of vaccination and statutory health insurance provider. The objective of this study was to estimate the risk of FC after a first dose vaccination with Priorix-Tetra™ compared to first dose vaccination with MMR or MMR+V vaccines in the pre-specified risk intervals: 0-4 days after immunization, 5-12 days after immunization (main risk interval), 13-30 days after immunization, and the entire risk period, that is 0-30 days after immunization.
Was this study requested by a regulator?Yes: Germany
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBIPS GmbH
Department/Research groupClinical Epidemiology
Organisation/affiliationLeibniz Inst. for Prevention Research and Epidem.
Website/Homepagewww.bips.uni-bremen.de
Details of (Primary) lead investigator
Title Dr
Last name Schink
First name Tania
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed14/01/201114/01/2011
Start date of data collection01/01/200401/01/2004
Start date of data analysis14/01/201114/01/2011
Date of interim report, if expected
Date of final study report30/09/201114/03/2012
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGlaxoSmithKline Biologicals SA100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schink
First name Tania
Address line 1Achterstraße 30
Address line 2 
Address line 3 
CityBremen 
Postcode28359 
CountryGermany
Phone number (incl. country code)49-421-21856865 
Alternative phone number 
Fax number (incl. country code) 
Email address schink@leibniz-bips.de
Public Enquiries
Title Dr 
Last name Schink 
First name Tania 
Address line 1Achterstraße 30 
Address line 2 
Address line 3 
CityBremen 
Postcode28359 
CountryGermany 
Phone number (incl. country code)49-421-21856865 
Alternative phone number 
Fax number (incl. country code) 
Email address schink@leibniz-bips.de 
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